Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study) (NCT03973866)
🩺 Plain-English Summary (8th-Grade Level)
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation phase after enrollment, followed by implantation of the alfapump and 24 months of post-implant follow up. An analysis will be conducted to support an application for device approval when a minimum of 40 treated pivotal cohort patients are through 6 months.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (32 items).
Location: Mayo Clinic (Arizona) — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: At the time of Initial Screening:
- Renal failure defined as serum creatinine higher than 1.5 mg/dL
- More than one episode of spontaneous bacterial peritonitis over the previous 6 months
- More than one episode of bacterascites over the previous 6 months
- Recurrent urinary infections as per standard criteria, defined as 2 or more episodes over the last 6 months
- Evidence of loculated ascites, as per imaging
- Hepatocellular carcinoma, exceeding Milan criteria or for which RF ablation is anticipated
- Pregnant females or females anticipating pregnancy during study period
- Patients currently enrolled in another interventional clinical study that has not reached the primary endpoint assessment point, or (for pivotal cohort) patients who have previously had an alfapump implanted
- Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months (corticosteroids at stable dose over the last 4 months but \< 15 mg/day, or in tapering doses are allowed)
- Known or suspected hepatic or extra hepatic malignancy (other than skin cancer and in-situ cancers), unless adequately treated or in complete remission for ≥ 3 years
- History of bladder cancer
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Mayo Clinic (Arizona) — Phoenix, Arizona
- Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Duke University — Durham, North Carolina
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- Avera Medical Group — Sioux Falls, South Dakota
- Methodist Dallas — Dallas, Texas
- Baylor University Medical Center (Dallas) — Dallas, Texas
- McGuire VA Medical Center — Richmond, Virginia
- Medical College of Wisconsin (Froedtert) — Milwaukee, Wisconsin
- Ottawa Hospital — Ottawa, Ontario
- Toronto General Hospital — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.